Comparative outcomes of simple versus radical hysterectomy in patients with and without very low-risk early-stage cervical cancer: An exploratory analysis from the Gynecologic Cancer Intergroup/Canadian Cancer Trials Group CX.5/ SHAPE trial

Abstract

Objective. To compare oncologic outcomes and perioperative morbidity between simple hysterectomy (SH) and radical hysterectomy (RH) in patients with and without very low-risk early-stage cervical cancer from the phase III Simple Hysterectomy And PElvic node assessment (SHAPE) trial. Methods. Patients who underwent SH or RH in the SHAPE trial were classified into the Conservative SHAPE group (very low-risk), meeting criteria similar to the ConCerv trial, and the Liberal SHAPE group (without very low-risk), including everyone else. Between the SH and RH arms in each group, survival outcomes, including recurrence-free survival (RFS) and overall survival (OS), and intraoperative and postoperative morbidities were compared. Factors associated with recurrence and mortality rates were also investigated. Results. In the Conservative SHAPE group (n = 107), no recurrence was observed in either SH or RH arms, and only one non-cancer-related death in the RH arm during a median follow-up of 4.5 years. In the Liberal SHAPE group (n = 575), the SH arm showed similar 3-year pelvic RFS (96.9 % vs. 97.4 %; HR, 1.15; 95 % CI, 0.49-2.70), extrapelvic RFS (97.7 % vs. 99.6 %; HR, 3.64; 95 % CI, 0.76-17.5), overall RFS (95.4% vs. 97.4 %; HR, 1.56; 95 % CI, 0.70-3.48), and OS (98.9% vs. 99.3 %; HR, 1.21; 95 % CI, 0.41-3.59), compared with the RH arm. In multivariate analyses, SH was not associated with recurrence and mortality rates, while absence of residual disease in the hysterectomy specimen was associated with lower recurrence. In both groups, SH was associated with a lower risk of urinary retention and incontinence. Conclusion. There were similar recurrence and survival outcomes but less morbidity from simple hysterectomy compared to radical hysterectomy in patients with and without very low-risk early-stage cervical cancer from the SHAPE trial. (c) 2026 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).